Alternative approaches involve the application and use of alternative test methods not involving the use of live animals and addressing the principles of the 3Rs (reduction, replacement, refinement). Even though we apply the 3R principles in our everyday work, the development and validation of new tests that do not involve animals is not a task that has been delegated to HPRA but has been retained by the Department of Health. Various EU bodies (e.g. EURL ECVAM and PARERE) are involved in such tasks.
Prior to conducting scientific research involving the use of animals, scientists should firstly demonstrate why a non-animal method cannot be used and clearly outline the scientific objective being addressed by the proposed scientific work. A number of resources are publically available to assist scientists with gathering 3R information. The European Union Reference Laboratory for alternatives to animal testing (EURL ECVAM) search guide on basic principles for data retrieval procedures provides a useful starting point and search tool for scientists.
PARERE (Preliminary Assessment of Regulatory Relevance)
- PARERE is an EU committee who assess the regulatory relevance of alternative test methods submitted to the European Centre for the Validation of Alternative Methods (ECVAM) for validation.
- Additional information can be found on the PARERE network can be found on the EURL ECVAM website.
Role of HPRA
- We endorse the application of alternative approach methods/models in research and industry in line with the principles of the 3Rs i.e. the replacement, the reduction or the refinement of proposed animal methods/models.
- We welcome any changes in research practice or relevant new approaches consistent with this principle.
We aim to promote the development and transition of alternative approaches through the adoption of alternative test approaches not involving the use of animals in Ireland, and through the timely dissemination of 3R information. Note that the HPRA is not the national competent authority for assisting the European Commission in identifying specialist laboratories to carry out validation studies on alternative test methods nor for providing advice on the regulatory relevance and suitability of alternative approaches that might be proposed for validation and regulatory acceptance.
We are reliant on application fees to cover the cost of providing our services. Accordingly, the HPRA does not have a budget to support the development and validation of non-animal alternative tests.